Sex Disparities in Hypoxic Vasodilation and Impact of Obesity

Healthy Clinical Trial

Official title:

Sex Disparities in Hypoxic Vasodilation and Impact of Obesity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05219799
• Other study ID #: 2080504
• Status: Recruiting
• Phase: Early Phase 1
• Start date: March 14, 2023
• Est. completion date: July 2025

Study information

• Verified date: February 2024
• Source: University of Missouri-Columbia
• Contact: Jacqueline K Limberg, Ph.D.
• Phone: 5738822544
• Email: limbergj[@]missouri.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this project is to examine key mechanisms contributing to sex-differences in hypoxic vasodilation and the impact of obesity, with particular emphasis on the sympathetic nervous system.

Description:

Patients with sleep apnea are at increased risk of developing cardiovascular disease - with women at potentially greater risk than men. Contributing mechanisms are not well understood, but may be related to how women respond to low oxygen and, given over 70% of patients with sleep apnea are obese, the impact of obesity. This project seeks to increase our understanding of mechanisms that may contribute to sex differences in the cardiovascular response to low oxygen with the hope that this knowledge will improve the efficacy of current therapies and support the discovery of novel therapeutics.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• BMI >18 kg/m2

Exclusion Criteria:

• Pregnancy, breastfeeding

• Diagnosed sleep apnea or AHI >10 events/hr

• Current smoking/Nicotine use

• Increased risk of bleeding, pro-coagulant disorders, clotting disorders, anticoagulation therapy

• Nerve/neurologic disease

• Cardiovascular, hepatic, renal, respiratory disease

• Blood pressure =140/90 mmHg

• Diabetes, Polycystic ovarian syndrome

• Communication barriers

• Prescription medications, Sensitivity to lidocaine

Related Conditions & MeSH terms

• Healthy
• Obesity
• Vasodilation

Intervention

Drug:
• Propranolol Hydrochloride
Regional forearm blockade of ß-adrenergic receptors at 20 mcg/dL/min via brachial artery catheter during normoxia and hypoxia exposures
• Isoproterenol
Dose response (1, 3, 6, and 12 ng/dL/min) regional infusion to assess ß-adrenergic receptor responsiveness
• Phentolamine Mesylate
This infusion will be for 10 min before baseline measurement (12 mcg/dL/min) and continue the infusion at a maintenance rate (5 mcg/dL/min).
• Norepinephrine
Regional forearm infusion at 8 ng/dL/min via brachial artery catheter during normoxia and hypoxia exposures

Locations

Country	Name	City	State
United States	University of Missouri	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in forearm vascular conductance with intra-arterial drug infusion	Vascular conductance is an index of vascular tone and is measured using a technique called venous occlusion plethysmography.	Change from baseline to last 1-minute of drug infusion